Regulatory Affairs Director ANDA Submissions (Remote)
Padagis
A leading generic pharmaceutical company is seeking an experienced Associate Director/Director of Regulatory Affairs to oversee regulatory strategies and manage submissions for pharmaceutical products. The role requires strong leadership in navigating FDA requirements, excellent project management skills, and a collaborative spirit. The candidate should have extensive experience in Regulatory Affairs, particularly with ANDA submissions. This remote position is ideal for candidates in the Minneapolis-St. Paul area. #J-18808-Ljbffr
- ...company is seeking an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for pharmaceutical products.... ...track record of managing ANDA, IND, NDA submissions. This position is remote eligible for candidates in the...Remote work
- ...is seeking an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products.... ...Affairs, particularly with ANDAs and FDA compliance. The position is available remotely for candidates located in...Remote work
- ...leading pharmaceutical company is seeking a Director of Regulatory Affairs located in Florida's Navarre to oversee regulatory strategies and submissions for generic products. The ideal... ...successful product development. This remote role is perfect for a strategic leader...Remote work
- ...leading pharmaceutical company is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for generic pharmaceutical products in... ...FDA for compliance. This position is remote eligible, specifically for candidates in...Remote work
- ...pharmaceutical company is seeking a Director or Associate Director of Regulatory Affairs in Round Lake, Illinois. The role... ...strategies, overseeing submissions, and ensuring compliance with FDA... ...experience in pharmaceuticals. This remote workplace eligible position offers...Remote work
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco,... ...strategies for drug approvals and submissions. Candidates should have extensive... ...experience in Regulatory Affairs CMC within the biotech or pharmaceutical... ...The position is hybrid, with remote work and occasional onsite...Remote job$130k - $160k
...overseeing the medical writing team and ensuring high-quality regulatory documents for market submissions. The role includes mentoring writers, managing... ...diagnostics or pharmaceutical sector. The position is fully remote, offering a compensation range of $130-160k with...Remote job$150k - $194k
...A biopharmaceutical company in San Diego seeks an Associate Director, Regulatory Affairs CMC. This role focuses on regulatory strategy execution for drug development. You will oversee regulatory submissions, maintain director-level interactions, and manage project timelines...Remote work- ...biotechnology company is seeking an Associate Director for Regulatory Affairs, CMC to manage global regulatory... ...with the FDA and producing CMC submissions. Ideal candidates will have 8+ years... ...a relevant degree. The position is remote in the US and offers a competitive salary...Remote work
$120k - $140k
...This position may be performed remotely, but requires the flexibility and... .... Position Summary Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee the operational... ...in conjunction with Regulatory Affairs strategy and CMC leads, cross‑...Remote workWork at officeLocal areaFlexible hours$155.68k - $202.38k
QuidelOrtho seeks a Senior Manager of Regulatory Affairs to lead and support regulatory strategies for the Transfusion Medicine Business Unit... ...specifically in regulatory strategy for product development. This remote eligible position prefers candidates from Raritan, NJ;...Remote work- ...Celcuity is seeking an Executive Director of Regulatory Affairs to lead and drive global regulatory strategies and compliance within the biopharmaceutical... ...to innovate and support international regulatory submissions. Celcuity offers a base pay range of $265,000–$300,000...Remote work
$228k - $245k
A biotechnology company in Missouri is seeking a Director of Global Regulatory Affairs responsible for developing and executing regulatory strategies... ...in regulatory affairs and a strong track record of submissions. The position offers a competitive salary of $228,000 to...Remote job- A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials...
$150k - $218k
...cures for cancer. DESCRIPTION: Join our Regulatory Affairs team at Thermo Fisher Scientific,... ...healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead... ...requirements, and ensure successful product submissions across various jurisdictions. Working...Work at officeWorldwide- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...commercializing products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and...
- A biotechnology firm is seeking a Director of Global Regulatory Affairs to develop and implement regulatory strategies for their clinical pipeline.... ...global regulatory requirements, and maintaining timely submissions to health authorities. Ideal candidates should have over...Remote job
$73 - $117 per hour
Job Title: Regulatory Affairs Director Location: North Carolina (100% Remote) Pay Range: $73-117/hr. Job Type: Contract with the potential to hire Schedule:... ..., with a focus on vaccines. Manage regulatory submissions and interactions with agencies such as FDA and...Remote workWeekly payContract workTemporary workFlexible hours- Job Title: Temporary Regulatory Affairs Strategy Director Location: Alameda, CA Type: Contract Compensation... ...hr Contractor Work Model: Onsite - Remote in PST Hours: 40.0 Responsibilities... ...competitor product approvals, and submissions. Establish relationships and networks...Remote workContract workTemporary workFor contractorsLocal area
- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5-10 years of experience in Regulatory CMC, a strong technical background in relatorette...Remote job
- ...we help along the way. Responsibilities The Senior Director of Regulatory Affairs is responsible for establishing regulatory direction... ...guiding and coordinating with R&D and HORA, reviewing ANDAs pre- or post-submission, proactively working with cross-functional teams,...Work at office
- ...experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible... ...regulatory strategies, submission requitements and writing... ...of the submissions are ANDAs for generic products in... ...entry. Note: This is a remote workplace eligible position...Remote work
- ...healthcare innovation company in San Diego is looking for a Regulatory Affairs Director to lead global regulatory strategies. This role requires... ...experience in the IVD industry, with a focus on FDA submissions. The ideal candidate will work cross-functionally to ensure...
$120k - $140k
...who finds creative solutions to complex regulatory challenges and takes pride in developing... ...governance, valuation protocols, and regulatory submissions across diverse jurisdictions Partner... ...We recognize the benefits of flexible, remote working arrangements for eligible roles...Remote workWork from homeFlexible hours- ...Senior Director, Regulatory & Scientific Affairs Job Category: Reg & Scientific Affairs Requisition Number: SENIO... ...Posted : March 9, 2026 Full-Time Remote Locations Showing 1 location... ...designations, and CGT‑specific CMC submissions. Advise cross‑functional teams on...Remote workFull timeContract workWork from home
- ...Regulatory Manager Location: Remote or Allen, TX Duration: 12 months Interpret, summarize and communicate local, state and federal broadband... ...inquiries related to broadband grant opportunities and submissions. Candidate Requirements Strong telecommunications...Remote workLocal area
- ...company focused on MASH and liver fibrosis is seeking a (Senior) Director, Regulatory Affairs. In this remote role, you will lead U.S. regulatory strategy, particularly for FDA engagement and regulatory submission mechanics. The ideal candidate should have 8+ years of...Remote work
$110k - $150k
...highly experienced and detail‑oriented UAS Regulatory Compliance Manager to lead the... ...Operations (CONOPS). Lead the drafting and submission of Declarations of Compliance and Statements... ...engineering data into clear documentation for FAA Remote ID (14 CFR Part 89) and type...Remote workWork at officeLocal areaWork from homeHome officeFlexible hours- ...Director, Regulatory Affairs – Permanent – Remote Proclinical is seeking a (Senior) Director, Regulatory Affairs for an exciting MASH‑focused biotechnology... ...data positioning, while overseeing regulatory submission mechanics executed by external service providers, with...Remote workPermanent employment
$90k - $105k
...About the Position:The Regulatory Affairs Manager will oversee assigned regulatory team staff, navigate submission/approval pathways, lead the development of new protocol submissions... ...of all assigned projects.This is a fully remote role supporting a program based out of the...Remote workWork experience placementFlexible hours
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